DDT COA #000119: PROMIS® Pediatric Chronic Kidney Disease Short Form- Sleep Disturbance
Clinical Outcome Assessments (COA) Qualification Submissions
Office of cardiology, Hematology, Endocrinology, and Nephrology (OCHEN)
Division of Cardiovascular and Nephrology (DCN)
DDT COA Number
DDT COA #000119
Instrument Name
PROMIS® Pediatric Chronic Kidney Disease Short Form- Sleep Disturbance
Disease/Condition
Chronic Kidney Disease (CKD)
Concept of Interest
Sleep Disturbance
Context of Use
Children (8-17 years) with CKD
COA Type
PRO
Qualification Stage
Letter of Intent- Accepted
Requestor(s)
Pediatric Patient Reported Outcomes in Chronic Diseases (PEPR) Consortium
Contact(s)
Julia Schuchard
Date Accepted into CDER’s COA Qualification Program
January 15, 2020
Submission and Regulatory Correspondence History
| Qualification Submission | Date | FDA Submission Decision & Recommendations | Date |
|---|---|---|---|
| Letter of Intent | 10/11/19 | FDA Response (Accepted) | 1/11/20 |